Coya Therapeutics has announced positive data from a small trial in Alzheimer’s disease as the company looks to build out its neurodegenerative disease platform.

In an 8-patient open label study, COYA-301 generated an anti-inflammatory response and halted decline in cognitive function. Houston Methodist Research Institute conducted the academic study.

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With early positive data in hand, Coya will consider partnering with another pharma company to co-develop COYA-301 as a combination therapy in Alzheimer’s, CEO Howard Berman told Clinical Trials Arena. COYA-301 is a low-dose interleukin-2 (IL-2), which could work in tandem with another anti-inflammatory agent, he explained.

In the meantime, Berman said Coya’s primary focus will be to develop COYA-302 in amyotrophic lateral sclerosis (ALS). Coya previously announced plans to initiate a new trial of COYA-302 in ALS later this year following positive data from a four-patient trial.

COYA-301 in Alzheimer’s disease

COYA-301 could enhance regulatory T cell (Treg) function and expand Treg numbers, which could suppress inflammation driving Alzheimer’s disease pathology. In the open-label trial, COYA-301 restored peripheral Treg function and numbers and lowered pro-inflammatory cytokines and chemokines.

However, COYA-301 only appears to result in a modest suppression of myeloid cells, which also contribute to neuroinflammation, Berman said. As a result, COYA-301 would work well as a combination with therapies able to target these cells, he noted.

Berman said that although the early-stage trial lacked a placebo arm, the data suggests that COYA-301’s effect on Tregs could slow or stop cognitive decline. “The Treg story is a critically important story in neurodegenerative diseases,” he added.

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